Product Reviewer – Medical Device Software (Contractor)

About the role

A partner company, acting on behalf of the hiring entity, is looking for a Product Reviewer – Contractor based in Estonia. You will independently assess the technical documentation and software lifecycle processes of medical device software, including Software as a Medical Device (SaMD) and AI-enabled solutions, and help manufacturers meet regulatory, technical and safety requirements. The position is fully remote with flexible scheduling.

Key responsibilities

• Independently deliver accurate, consistent and high-quality technical assessments of medical device software documentation.
• Evaluate compliance with EU MDR, UK MDR, IEC 62304, IEC 82304-1, IEC 62366-1 and IEC 81001-5-1.
• Review software development and lifecycle documentation to verify that regulatory and technical requirements are met.
• Identify, document, communicate and follow up on assessment findings with manufacturers, explaining them clearly and constructively.
• Work with manufacturers to clarify technical issues and close out findings.
• Apply independent judgment with minimal supervision and use established assessment workflows and tools.

Required profile

• Bachelor's degree or higher in Software Engineering, Computer Science, Electrical or Electronic Engineering or a closely related field.
• At least 4 years of professional experience in the medical device industry or another safety-critical sector.
• At least 2 years of experience designing, developing or testing safety-critical software.
• Previous experience as a Product Reviewer or technical documentation assessor for a notified body or UK approved body, covering software devices such as MDA 0315 or MDS 1011.
• Experience assessing SaMD and strong written and verbal communication skills.

Required skills

• Working knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, IEC 81001-5-1 and MDCG 2019-16.
• Practical understanding of software development fundamentals, verification and validation testing, configuration management and cybersecurity.
• Ability to interpret and apply regulatory requirements when assessing technical documentation.
• Preferred: experience with AI and machine learning-enabled devices and familiarity with LLMs, RAG, fine-tuning and model evaluation.

What we offer

• Fully remote contractor position with flexible scheduling.
• Exposure to EU MDR, UK MDR and IEC standards, and to innovative medical device software including AI-enabled technologies.